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FDA 510(k)

DISCO SUBTALAR IMPLANT

K-Number: K111834 · 2011-12-06

ApplicantTrilliant Surgical, Ltd.
Decision Date2011-12-06
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

DISCO SUBTALAR IMPLANT is the device name listed in this FDA 510(k) record. The listed applicant is Trilliant Surgical, Ltd.. It received FDA 510(k) clearance on 2011-12-06 under 510(k) number K111834. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DISCO SUBTALAR IMPLANT?

DISCO SUBTALAR IMPLANT is a medical device that received FDA 510(k) clearance on 2011-12-06. The listed applicant is Trilliant Surgical, Ltd.. The 510(k) number is K111834.

When did DISCO SUBTALAR IMPLANT receive FDA 510(k) clearance?

DISCO SUBTALAR IMPLANT received FDA 510(k) clearance on 2011-12-06, under 510(k) number K111834.

Who is the listed applicant for DISCO SUBTALAR IMPLANT?

The FDA 510(k) record lists Trilliant Surgical, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DISCO SUBTALAR IMPLANT?

The FDA product code for DISCO SUBTALAR IMPLANT is HWC. This falls under the Cardiovascular category.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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